N/A
N=40
Feasibility of an Activity Regimen in Patients With Advanced Stage Lung Cancer
Lung Neoplasm Malignant
Bottom Line
View on ClinicalTrials.gov: NCT03352245 ↗Enrolled (actual)
40
Serious AEs
10.0%
Results posted
May 2021
Primary outcome: Primary: Overall Step Count — 4707; 5605; 4606 Steps
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prescribed Activity (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Step Count |
4707; 5605; 4606 | — |
| PRIMARY Number of Weeks Participants Adhered to Step Count Recommendations |
47 | — |
| SECONDARY Dyspnea |
-0.04; -0.07 | 0.889 |
| SECONDARY Depression |
-0.83; 0.31 | 0.20 |
| SECONDARY Change in Quality of Life: Global Health Status |
3.16; -4.63 | 0.166 |
| SECONDARY Change in Quality of Life: Physical Functioning |
4.11; 4.74 | 0.853 |
| SECONDARY Change in Quality of Life: Role Functioning |
8.09; -8.95 | 0.022 sig |
| SECONDARY Change in Quality of Life: Emotional Functioning |
2.68; 3.11 | 0.911 |
| SECONDARY Change in Quality of Life: Fatigue |
-4.43; 0.75 | 0.456 |
| SECONDARY Change in Quality of Life: Cognitive Functioning |
0.41; 2.47 | 0.515 |
| SECONDARY Change in Quality of Life: Nausea/Vomiting |
-2.44; 6.21 | 0.144 |
| SECONDARY Change in Quality of Life: Pain |
1.67; 1.26 | 0.948 |
| SECONDARY Change in Quality of Life: Social Functioning |
-4.22; 4.40 | 0.254 |
| SECONDARY Change in Quality of Life: Dyspnea |
-6.19; 7.12 | 0.051 |
| SECONDARY Change in Quality of Life: Insomnia |
0.58; -3.49 | 0.643 |
| SECONDARY Change in Quality of Life: Appetite Loss |
-4.16; 4.95 | 0.290 |
| SECONDARY Change in Quality of Life: Constipation |
-1.21; -11.19 | 0.077 |
| SECONDARY Change in Quality of Life: Diarrhea |
0.14; -5.13 | 0.237 |
| SECONDARY Change in Quality of Life: Financial Difficulties |
6.56; 5.41 | 0.861 |
| SECONDARY Moderate Aerobic Exercise |
37.0; 58.8; 128.1; 75.3 | — |
| SECONDARY Vigorous Aerobic Exercise |
0.0; 0.0; 32.0; 17.4 | — |
| SECONDARY Change in C-reactive Protein (CRP) |
-1,381.34; -1,242.47 | — |
| SECONDARY Change in Leptin Level |
0.34; -3.31 | — |
| SECONDARY Change in Insulin Level |
5.08; 8.32 | — |
| SECONDARY Programmed Death - Ligand |
1.22; -11.08 | — |
| SECONDARY Programmed Cell Death (PD-1) |
152.76; -67.03 | — |
Summary
The investigators will evaluate the feasibility of implementing a low-intensity, patient-centered activity regimen (PCAR) that prioritizes education and communication over a 12-week period in advanced stage lung cancer patients. The primary outcomes will include number of patients increasing their overall step count over the study period and adherence to step count recommendations. Secondary outcomes will include quality of life (QoL), dyspnea, and depression scores before and after the intervention as well as a patient feedback questionnaire (to guide further interventions). The goals are to increase overall step count and obtain adherence of >50% of participants. The investigators will also assess whether the physical activity regimen influences markers of inflammation and glucose control and novel markers of cancer.
Eligibility Criteria
Inclusion Criteria
- Pathologic evidence of advanced non-small cell stage lung cancer (NSCLC)
- Approval of the treating clinician
- Adult patients (age >21 years) willing to wear a FitBit® device (FitBit, Inc., San Francisco, CA)
- Access to a smartphone, agree to receive twice/daily text messages for 12 weeks (including any costs), and willingness to download the FitBit application to their smartphone.
- Low activity level as judged by a brief physical activity questionnaire (i.e., <150 minutes/week of moderate-intensity exercise, <75 minutes/week of vigorous aerobic exercise, or an equivalent combination).
Exclusion Criteria
- Memory impairment (as judged by the treating clinician)
- Communication impairment (as judged by the treating clinician)
- Treating clinician's request not to alter physical activity
- Physical inability to safely walk (as judged by the treating clinician)
Data sourced from ClinicalTrials.gov (NCT03352245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.